Investigating the effect of sublingual squalene on the number of hospitalization days due to pneumonia in children hospitalized in intensive care units

determine and compare the effect of sublingual squalene on the duration of hospitalization and the clinical course of pneumonia in patients admitted to the pediatric intensive care unit.

In this study, the number of required patients with pneumonia was found to be 52, in equal control and intervention groups of 26 people by random selection. The sampling method is available and the research units are randomly grouped into 2 intervention and control groups.

The setting of the study is the ICU departments of Akbar Specialized and Subspecialized Children’s Hospital Mashhad.In the interventional group apart from the conventional antibiotic regimen, sublingual squalene 10 mg is administered for five days. In the control group, however, participants receive standard drug treatment only.

Some of the entry criterion are: the child’s guardian has signed an informed consent form. Covid pneumonia requiring admission in the ICU based on recent IDSA guidelines Two months to 18 years old No immunodeficiency, no pre-existing cardiovascular disease, chronic lung disease, no metabolic disease, anatomical anomalies These are such as withdrawal of cooperation and no further contact. The patient died within the period of 6 days follow up

In addition to the standard pneumonia treatment, the intervention group is treated daily with 10 mg squalene sublingually for 5 days.

Primary outcomes: body temperature, heart rate, blood pressure, respiration rate, blood oxygenation rate, CRP, ESR, WBCBC, lung involvement rate, number of days in hospital Secondary outcomes: mortality, readmission within the next 30 days

The sampling method is available and the research units are therefore randomly partitioned into 2 intervention as well as control groups. In this study, permutation block method will be used in an attempt to produce the sequence of people’s random allocation into the groups under study. Sequence of random allocation of people will be done using Random Allocation Software and block size is 4.In this study, 4 blocks of 4 ABAB (1), ABBA (2), ABABBA (3), BBAA (4) will be our guide in this study. Some of the numbers of a block appear at random. If the first block selected is ABAB, the samples are then split into two groups and this process is continued until all the samples are assigned.If the consequence of the concealment of the random allocation before the allocation of the individual is going to be compromised, then the random sequences generated are recorded onto a card and placed inside separate envelopes in turn.In order to further preserve the sequence, the outside of the envelopes is numbered in the same sequence. Last, the last lid of the envelopes are glued and they are all placed into a box. In the first stage at the time of the entry of the participants, as per the first come first served basis for the number of participants who are having the eligible criteria to enter into the study ,as and when the participant is ensuring to enter the study ,one of the envelopes from the above prepared envelopes will be opened consequent to the name and code number of every individual, to reveal the group that is assigned to that participant.

The target beneficiaries are the patients, care givers/health care personnel (doctors, nurses, physiotherapists, etc.), data gatherers and outcome assessors.

There is no further information